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TABLE OF CONTENTS
CHAPTER 12
INSTITUTIONAL PHARMACY PRACTICE REGULATIONS
Section 1.
Section 2.
Section 3.
Section 4.
Section 5.
Section 6.
Section 7.
Section 8.
Section 9.
Section 10.
Section 11.
Section 12.
Section 13.
Section 14.
Section 15.
Section 16.
Section 17.
Section 18.
Section 19.
Section 20.
Section 21.
Section 22.
Authority
Purpose
Scope of Chapter
Definitions
Licensing
Change of Ownership
Personnel
Environment
References
Equipment
Security
Absence of Pharmacist
Emergency Outpatient Medication
Emergency Drug Carts
Automated Dispensing Devices
Parenteral Medications
Practitioner’s Orders
Dispensing
Investigational Drugs and Protocols
Monthly Inspection
Medications Brought Into The Institution By Patients
Controlled Drugs
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CHAPTER 12
INSTITUTIONAL PHARMACY PRACTICE REGULATIONS
Section 1.
Authority.
These regulations are promulgated as authorized by the Act.
Section 2.
Purpose.
The purpose of this Chapter is to provide standards for the conduct, practice
activities, and operation of a pharmacy located in a hospital or other inpatient facility that
is licensed under the Wyoming Department of Health. The intent of these standards is to
establish a minimum acceptable level of pharmaceutical care to the patient so that the
patient’s health is protected while contributing to positive patient outcomes.
Section 3.
Scope of Chapter.
This Chapter applies to any person, partnership, corporation, limited liability
company, or other entity engaging in the practice of pharmacy in an Institutional Facility,
as defined below, within this state.
Section 4.
Definitions.
(a) “Institutional Facility” means a hospital, convalescent home, nursing home,
extended care facility, correctional or penal facility, or any other organization, public or
private, which provides a physical environment for patients to obtain medical, surgical,
and/or nursing services, except those places where physicians, dentists, veterinarians, or
other practitioners of the healing arts engage in private office practice.
(b) “Institutional Pharmacy” means a pharmacy where medications are
dispensed to other health care professionals for administration to institutionalized patients
served by an Institutional Facility, and which is:
(i)
Located within the Institutional Facility, or
(ii)
Located outside the Institutional Facility but only provides
pharmaceutical services to institutionalized patients.
(c)
“Drug Room” means a secure and lockable location within an inpatient
care facility that does not have an Institutional Pharmacy.
(d)
“Floor Stock” means prescription drugs not labeled for a specific patient
and maintained at a nursing station or other Institutional Facility department (excluding
the Institutional Pharmacy) for the purpose of administration to a patient of the
Institutional Facility.
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(e)
“Formulary” means a continually revised compilation of pharmaceuticals
that reflects the current clinical judgment of the medical staff of the Institutional Facility.
(f)
“Medication Order” means a written, electronic, or verbal order from a
practitioner (or his/her agent) authorized by law to prescribe medications for
administration to a patient.
(g)
“Emergency Drug Cart (crash cart)” means a cart containing those drugs
that may be required to meet the immediate therapeutic needs of inpatients or emergency
room patients and are not available from any other authorized source in sufficient time to
prevent risk of harm to patients by delay resulting from obtaining such drugs from such
other source.
(h)
“Clean Room” means a room with a minimum of an ISO Class 7
environment:
(i) in which the concentration of airborne particles is controlled;
(ii) that is constructed and used in a manner to minimize the
introduction, generation, and retention of particles inside the room;
(iii) in which other relevant variables (e.g., temperature, humidity, and
pressure) are controlled as necessary; and
(iv) in which microorganisms in the environment are monitored so that
a microbial level for air, surface, and personnel gear is not exceeded for a specific
cleanliness class.
(i)
“Investigational Drug” means:
(i) a substance in a clinical stage of evaluation not released by the
Food and Drug Administration for general use or for sale in interstate commerce; or
(ii) Commercial drugs that are proposed for a new use, contain a new
component, have a new dosage or mode of administration, or are in a new combination or
combined in new proportions.
(j)
“Remote Order Processing for Institutional Pharmacies” includes any of
the following activities performed for an Institutional Pharmacy from a remote location:
(i) Receiving, interpreting, or clarifying medication orders;
(ii) Entering or transferring medication order data;
(iii) Performing prospective drug use review;
(iv) Obtaining substitution authorizations;
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(v) Interpreting and acting on clinical data;
(vi) Performing therapeutic interventions;
(vii) Providing drug information;
(viii) Authorizing the release of a medication for administration.
Section 5.
Licensing.
(a)
All institutional pharmacies shall register annually with the Board of
Pharmacy on a form provided by the Board. Institutional Pharmacies that also provide
outpatient pharmacy services shall also register as a retail pharmacy.
(b)
All Institutional Pharmacy licenses shall expire on June 30. Renewal
notices will be sent by the Board’s office at least sixty days prior to June 30.
(c)
The fee established in Wyoming Pharmacy Act, Rules and Regulations
Chapter 2, Section 25(a)(xi), will be charged for issuance of a new license and renewal.
The late fee established in Wyoming Pharmacy Act, Rules and Regulations, Chapter 2,
Section 25 (b)(vi), will be charged, in addition to the renewal fee, for any license renewal
application that is postmarked after June 30 or is hand-delivered to the Board office after
June 30.
Section 6.
Change of Ownership.
(a)
If an Institutional Pharmacy changes ownership, it must obtain a new and
separate registration from the Board. In the case of a corporation, limited liability
company, or partnership holding an Institutional Pharmacy license, the Board shall be
notified and a new license applied for any time the majority of stock in the corporation is
sold or a majority of the partners of the partnership or members of the limited liability
company change.
Section 7.
Personnel.
(a)
A pharmacist, hereinafter referred to as the Pharmacist-in-Charge (PIC),
who is licensed to engage in the practice of pharmacy in Wyoming, shall direct each
Institutional Pharmacy.
(b)
The storage, compounding, repackaging, dispensing, and distribution of
drugs by an Institutional Pharmacy shall be under the direction, supervision, and
responsibility of the PIC. Depending upon the size and needs of the Institutional Facility,
pharmacy service may be provided on a full or part-time basis.
(i) In hospital Institutional Facilities with fifty (50) or more acute care
beds, a pharmacist shall be in the hospital Institutional Facility during the time the
Institutional Pharmacy is open for pharmacy services, except in case of emergencies.
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Pharmacy services shall be provided for a minimum of forty (40) hours per week, unless
an exception is made upon written request by the hospital Institutional Facility and with
express permission of the Board.
(ii)
In hospital Institutional Facilities with less than fifty (50) acute
care beds, a pharmacist shall be in the hospital Institutional Facility during the time the
Institutional Pharmacy is open for pharmacy services. Upon written request by the
hospital Institutional Facility, and with the express permission of the Board, the services
of a pharmacist may be on a part-time basis, according to the needs of the hospital
Institutional Facility. The services of a pharmacist shall be required as follows:
(A) In hospital Institutional Facilities with one to twenty-five (125) acute care beds, a pharmacist shall be available a minimum of five (5) hours per
week.
(B) In hospital Institutional Facilities with twenty-six to fortynine (26-49) acute care beds, a pharmacist shall be available a minimum of twenty (20)
hours per week.
(iii)
In a non-hospital Institutional Facility, a pharmacist shall be
available commensurate with the needs of the Institutional Facility. The hours shall be
identified on the initial application and provided with each license renewal.
(c)
Policies and procedures defining the pharmaceutical services to be
provided and the responsibilities of the Institutional Pharmacy shall be established. Such
policies and procedures shall be made available to the Board and/or its authorized
representative upon request.
(d)
The responsibilities of the PIC shall include, at a minimum, the following:
(i) Providing the appropriate level of pharmaceutical care services to
patients of the Institutional Facility;
(ii)
Ensuring that drugs and/or devices are dispensed and distributed
safely and accurately as prescribed;
(iii)
Developing a system for the compounding, sterility assurance,
quality assurance, and quality control of sterile pharmaceuticals compounded within the
Institutional Pharmacy;
(iv) Developing a system to assure that all Institutional Pharmacy
personnel responsible for compounding and/or supervising the compounding of sterile
pharmaceuticals within the Institutional Pharmacy receive appropriate education,
training, and competency evaluation;
(v)
Providing guidelines and approval of the procedure to assure that
all pharmaceutical requirements are met when any part of preparing, sterilizing, and
labeling of sterile pharmaceuticals is not performed under direct Institutional Pharmacy
supervision;
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(vi) Participating in the development of a Formulary for the
Institutional Facility which is approved by the appropriate committee, including the
medical staff of the Institutional Facility;
(vii)
Developing a system to assure that drugs to be administered to
inpatients are distributed pursuant to an original or direct copy of the practitioner’s
Medication Order;
(viii)
Maintaining records of all transactions of the Institutional
Pharmacy as may be required by applicable state and federal law, and as may be
necessary to maintain accurate control over and accountability for all pharmaceutical
materials, including pharmaceuticals and components used in the compounding of
pharmaceuticals;
(ix) Participating in those aspects of the Institutional Facility’s patient
care evaluation program that relate to pharmaceutical utilization and effectiveness;
(x)
Assuring that a reasonable effort is made to obtain, record, and
maintain patient medication records;
(xi) Assuring the legal operation of the Institutional Pharmacy,
including meeting all inspection and other requirements of state and federal laws or rules
governing the practice of pharmacy; and
(xii) Collaborating with the nursing staff and the medical staff to
develop a list of standardized concentrations of medications that will be used in the
Institutional Facility (e.g., therapeutic heparin intravenous infusions).
Pediatric
formulations will be considered as a separate listing from adult formations.
(e)
The PIC shall be assisted by a sufficient number of additional licensed
pharmacists as may be required to operate the Institutional Pharmacy competently, safely,
and adequately to meet the needs of the patients of the Institutional Facility. All
pharmacists shall assist the PIC in meeting the responsibilities as outlined in Subsection
(c) of this Section and in ordering, accounting for, and other administrative duties
regarding pharmaceutical products.
(f)
Pharmacy technicians may assist the PIC, provided the ratio of pharmacy
technicians and pharmacy technicians-in-training to licensed pharmacists does not exceed
three to one (3:1). The duties of the pharmacy technicians or pharmacy technicians-intraining shall be established by the PIC and may not exceed the responsibilities as
outlined in Wyoming Pharmacy Act, Rules and Regulations, Chapter 10.
(g)
The PIC may be assisted by secretarial and clerical assistance as required
to assist with record-keeping, report submission, and other administrative duties.
Section 8.
(a)
Environment.
The Institutional Pharmacy shall be enclosed and lockable.
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(b)
The Institutional Pharmacy shall have adequate space necessary for the
storage, compounding, labeling, dispensing, and sterile preparation of drugs prepared in
the Institutional Pharmacy, depending on the size and scope of pharmaceutical services
provided.
(c)
A sink with hot and cold running water, exclusive of restroom
facilities, shall be available to all Institutional Pharmacy personnel and shall be
maintained in a sanitary condition at all times.
(d)
The Institutional Pharmacy shall be arranged in an orderly fashion and
shall be kept clean. All required equipment shall be clean and in good operating
condition.
(e)
The Institutional Pharmacy shall be properly lighted and ventilated.
(f)
The temperature of the Institutional Pharmacy shall be maintained within a
range of 59 to 86 degrees Fahrenheit (15 to 30 degrees Centigrade). The temperature of
the refrigerator shall be maintained within a range of 36 to 46 degrees Fahrenheit (2 to 8
degrees Centigrade) and the freezer shall be maintained within a range of –13 to +14
degrees Fahrenheit (-25 to –10 degrees Centigrade).
(g)
The Institutional Pharmacy shall store antiseptics, other drugs for external
use, and disinfectants separately from internal and injectable medications.
(h)
If the Institutional Pharmacy compounds sterile pharmaceuticals, they
shall be prepared in accordance with Wyoming Pharmacy Act, Rules and Regulations,
Chapter 17.
Section 9.
References.
Each Institutional Pharmacy shall maintain in its library at least one current
reference (text or electronic format, including online access or PDA) from each category
listed below. The Board reserves the right to accept new references in lieu of the
following:
(a)
Drug Monograph Reference:
(i) American Hospital Formulary Service®
(ii) Drug Facts and Comparisons®;
(iii) Thomson’s Micromedex®;
(iv) USPDI® Volume I, Drug Information for the Health Care
Professional; or
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(v) Drug Information Handbook (Lexi-Comp).
(b)
Stability and Incompatibility Reference:
(i) Handbook on Injectable Drugs, Lawrence A. Trissel;
(ii) King Guide to Parenteral Admixtures; or
(iii) Thomson’s Micromedex®.
(c)
Reference on Drug Availability and Identification:
(i) American Hospital Formulary Service® ;
(ii) Drug Facts and Comparisons®;
(iii) American Drug Index; or
(iv) Drug Information Handbook (Lexi-Comp) .
(d)
Drug Interactions:
(i) American Hospital Formulary Service®
(ii) Thomson’s Micromedex®;
(iii) Drug Interactions Facts;
(iv) USPDI® Volume I, Drug Information for the Health Care
Professional;
(v) Drug Information Handbook (Lexi-Comp) ;
(vi) Drug Interactions Analysis and Management (DIAM) ;
(e)
Reference on Pharmacology and Therapeutics:
(i) Conn’s Current Therapy (Rakel and Bope) ;
(ii) Drug Information Handbook (Lexi-Comp) ;
(iii) Applied Therapeutics: The Clinical Use of Drugs (Koda-Kimble);
(iv) Pharmacotherapy (DiPiro); or
(v) Textbook of Therapeutics (Herfindal and Gourley) .
(f)
Current copies of the Wyoming Pharmacy Act and Rules and Regulations,
and Wyoming Controlled Substance Act and Rules and Regulations, text or electronic
format, and including internet access to the Board website.
(g)
Wyoming State Board of Pharmacy Quarterly Newsletter, maintained in a
binder.
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Section 10.
Equipment.
(a)
Institutional pharmacies distributing Medication Orders shall have the
following equipment:
(i) Refrigerator, including a system or device to monitor the
temperature daily to ensure that proper storage requirements are met;
(ii)
Computer and software appropriate for the Institutional Facility;
(iii)
Facsimile capability located in the Institutional Pharmacy.
and
(b)
If the Institutional Pharmacy compounds Medication Orders that require
the use of a balance, a Class A prescription balance or electronic scale with 10 mg
sensitivity shall be available. Such balance or electronic scale shall be properly
maintained by the PIC and may be inspected at least every three (3) years by the Board of
Pharmacy.
(c)
If the Institutional Pharmacy compounds sterile pharmaceuticals, the
Institutional Pharmacy shall have equipment and supplies listed in Wyoming Pharmacy
Act, Rules and Regulations Chapter 17.
Section 11.
Security.
(a)
No one shall be permitted in the Institutional Pharmacy unless the
pharmacist is on duty, except as provided in this Chapter, Section 12. If the pharmacist
must leave the Institutional Pharmacy for an emergency or patient care duties, pharmacy
technicians may remain to perform duties as authorized by the Pharmacist-in-Charge
(PIC), provided that the pharmacist remains in the Institutional Facility.
(b)
All Institutional Pharmacy areas shall be capable of being locked by key
or programmable lock, so as to prevent access by unauthorized personnel. The Director
shall designate in writing, by title and specific area, those persons who shall have access
to specific Institutional Pharmacy areas.
(c)
Each pharmacist on duty shall be responsible for the security of the
Institutional Pharmacy, including provisions for adequate safeguards against theft or
diversion of drugs including controlled substances and the records thereof.
(d)
Pharmacists, technicians, clerical staff, and interns working in the
Institutional Pharmacy shall wear identification badges, including name and position,
whenever on duty.
(e)
The PIC shall be responsible for policies and procedures for the safe
distribution and control of prescription blanks bearing identification of the Institutional
Facility.
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Section 12.
Absence of Pharmacist.
(a)
General. During such times as Institutional Pharmacy services are not
available on-site, arrangements shall be made in advance by the Pharmacist-in-Charge
(PIC) for provision of drugs to the medical staff and other authorized personnel of the
Institutional Facility by use of Floor Stock and/or access to the Institutional Pharmacy
under the standing order of the PIC.
(b)
If Floor Stock is used, the following shall prevail:
(i) In the absence of a registered pharmacist, medication for inpatients
shall be obtained from a locked cabinet(s) or other enclosure(s) located outside the
Institutional Pharmacy to which only nurses, specifically authorized in writing by the
PIC, may obtain access by key or combination, and which is sufficiently secure to deny
access to unauthorized persons.
(ii)
The PIC shall, in conjunction with the appropriate committee, if
any, of the Institutional Facility, develop inventory listings of those drugs to be included
in such Floor Stock, and shall ensure that:
(A)
Such drugs are available therein, properly labeled;
(B)
Such drugs are prepackaged in appropriate small amounts,
unless commercially prepared package, e.g. ophthalmics, otics, topicals, etc.
(C)
All drugs therein shall be checked and replenished as
needed;
(D)
A record shall be made on a copy of the physician’s order
or in a separate file or logbook located where the Floor Stock is maintained, and shall
include:
(I) The date and time of removal of a drug;
(II) The patient’s name and location;
(III) The name, strength, dosage form, and quantity of
drug removed; and
(IV) The signature of the nurse removing the drug.
(E)
The nurse removing the drug shall leave a direct copy of
the new physician’s order for the medication with the above record or, if the copy of the
physician’s order is utilized in place of the log book, then this copy must be left in a
designated area where Floor Stock is maintained; and
(F)
Written policies and procedures are established to
implement the requirements of this Paragraph.
(c)
Access to the Institutional Pharmacy. Whenever any drug is not available
from Floor Stock, and such drug is required to treat the immediate needs of a patient
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whose health would otherwise be jeopardized, such drug may be obtained from the
Institutional Pharmacy, in accordance with the requirements of this Paragraph. Only
supervisory or charge nurses may have access to the Institutional Pharmacy and may
remove drugs therefrom. Such nurses shall be designated in writing by the PIC.
(i) Removal of any drug from the Institutional Pharmacy by an
authorized nurse must be recorded on a suitable form at the Institutional Pharmacy
showing:
(A)
The date and time of the removal of the drug;
(B)
The patient’s name and location;
(C)
The name, strength, dosage form, and quantity of drug
(D)
The signature of the nurse.
removed; and
(ii)
The nurse removing the drug shall leave a copy of the physician’s
order for the new drug with the above record.
(iii)
The quantity of drug removed shall not exceed the amount of
medication needed until the Institutional Pharmacy reopens. Drugs that are usually
dispensed as a unit of use package, such as MDIs, otics, topicals, insulin, and
ophthalmics, are excluded.
(iv) A procedure shall be established to allow verification by the
pharmacist of the drug removed (such as by leaving the identifying container or unit-dose
sample of the drug with the records).
(d)
If off-site pharmaceutical care is provided whenever an Institutional
Pharmacy is closed, then the following requirements must be met:
(i) The Institutional Pharmacy shall have a pharmacist on duty at the
Institutional Facility the minimum number of hours required in this Chapter, Section 7.
(ii)
Any pharmacist providing off-site pharmaceutical care under this
Section shall be licensed to practice pharmacy in Wyoming.
(iii) The Board shall be notified in writing by the Institutional
Pharmacy of any arrangement whereby pharmaceutical care is provided off-site. This
notification shall include the following:
(A)
The name, address, and Wyoming license number of each
pharmacist who will be providing this service.
(B)
The name, address, and Wyoming license number of each
pharmacy exchanging information with the Institutional Facility.
(C)
Description of the audio, video, and data link that will be
utilized to exchange information between the Institutional Facility and the off-site
pharmacist.
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(D)
Description of the scope of work of any pharmacist who
provides off-site pharmaceutical care under this Section.
(E)
Description of patient information that is to be shared
between the Institutional Facility and the off-site pharmacist. At minimum, the off-site
pharmacist shall have access to the patient's medical record.
(iv)
A pharmacist providing off-site pharmaceutical care may perform
Remote Order Processing, if the pharmacist has access to appropriate patient information,
including laboratory results.
(v)
A pharmacist providing off-site pharmaceutical care shall provide
the following services as a minimum:
(A)
Review of any new Medication Order or change in existing
Medication Order prior to administration by the nursing staff at the Institutional Facility.
(B)
Review of all sterile compounding performed by nursing
staff. Medications compounded during cardiopulmonary resuscitation or similar medical
emergency or procedure shall be exempt from an off-site pharmacist review prior to
administration. In all other circumstances, all sterile compounding is subject to review
by the off-site pharmacist.
(C)
The off-site pharmacist shall communicate with the
Institutional Pharmacy staff on a daily basis or, if the Institutional Pharmacy is not
opened on a daily basis, then communication shall occur whenever the Institutional
Pharmacy is open for business.
Section 13.
Emergency Outpatient Medication.
(a)
Institutional Facilities, which provide for the administration and
distribution of emergency pharmaceuticals to outpatients and/or inpatients being
discharged during hours when normal community or outpatient Institutional pharmacy
services are not available, may:
(i) Allow a designated nurse on the original written or electronic order
of a practitioner to administer and distribute medications pursuant to the following
requirements:
(A)
A written or electronic order of a practitioner authorized to
prescribe a drug is presented.
(B)
The medication is prepackaged by a pharmacist or a
technician under a pharmacist’s supervision or is administered and distributed utilizing an
automated drug dispensing device;
(C)
The quantity of medication administered and distributed is
limited to a seventy-two hour (72-hour) supply. Exceptions to the 72-hour supply
include: pediatric antibiotic preparations (PO), otics, ophthalmics, topicals, or metered
dose inhalers; and
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(D)
The labeling of the administered and distributed medication
includes:
(I)
Name, address, and telephone number of the l
Institutional Facility;
(II)
Name of patient;
(III)
Name of drug, strength, and quantity;
(IV)
Directions for use;
(V)
(VI)
Date;
Accessory cautionary information, as required for
patient safety;
(VII)
(VIII)
Name of practitioner; and
Initials of the nurse administering and distributing
the medication.
(b)
The order may be in the form of a separate written or electronic
prescription or a prescription entered in the patient’s medical record. A practitioner must
sign the order. A copy of the prescription order must be readily available for review by
the pharmacist.
(c)
A record shall be maintained for recording all medications administered
and distributed from the Institutional Facility’s emergency room. The record shall
include the following information:
(i)
Name of patient;
(ii)
Date of issuance;
(iii)
Name of drug;
(iv)
Patient’s Institutional Facility record number; and
(v)
Initials of the nurse who administered and distributed the drug.
(d)
The emergency room log for drugs administered and distributed after
hours shall be reviewed by the pharmacist at least weekly. Inventory levels will be
compared to drugs administered and distributed. Discrepancies will be reviewed with the
emergency room nursing supervisor.
(e)
Security of all drugs prepackaged must be maintained in a locked cabinet
or storeroom location in the emergency room area to which only specifically authorized
personnel shall have a key or combination.
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Section 14.
Emergency Drug Carts.
Emergency Drug Carts may be used by Institutional Facilities if:
(a)
All drug kits are supplied, and kept up-to-date, under the supervision of a
licensed pharmacist;
(b)
A committee composed of the Pharmacist-in-Charge, nursing staff, and
medical staff of the Institutional Facility develops a standard drug inventory, including
kind and quantity of each drug;
(c)
All drug kits are equipped with a breakable seal, and are secure from
access by unauthorized persons;
(d)
A listing of all drugs, their respective strength, quantity, and location, shall
be placed on the cart in a conspicuous location. If the pharmacy which services this
Emergency Drug Cart is not located within the Institutional Facility, the name, address,
and telephone number of the pharmacy shall be displayed in a conspicuous location;
(e)
All drugs are properly labeled;
(f)
The drugs are distributed, pursuant to a valid order, by authorized
personnel, and the pharmacist is notified of entry into the Emergency Drug Cart; and
(g)
The pharmacist, nursing staff, and medical staff develop and implement
written policies and procedures for using Emergency Drug Carts
Section 15.
Automated Dispensing Devices.
(a)
No drug shall be distributed or issued by the use of any automated
dispensing device unless the device and method of operation have been found by the
Board to ensure the purity, potency, and integrity of the drug, and to protect the drug
from diversion, and provided that:
(i) The device shall be stocked with drugs only by or under the
supervision of a pharmacist;
(ii)
The device shall be used only for the furnishing of drugs for
administration to patients of that Institutional Facility; and
(iii)
At the time of removal of any drug from the device, it shall
automatically make a written or electronic record to be retained by the pharmacist for at
least one (1) year, indicating:
(A)
The date of removal of the drug;
(B)
The name, strength, dosage form, and quantity of drug
removed;
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(C)
The name of the patient for whom the drug was ordered;
(D)
The name or identification code of the nurse removing the
and
drug from the device.
Section 16.
Parenteral Medications.
(a)
The Pharmacist-in-Charge (PIC) shall be responsible for the preparation,
sterilization, labeling, and dispensing of parenteral medications prepared within the
Institutional Facility and shall participate in the education and training, including the
provision of appropriate incompatibility information, of all personnel involved in the
preparation of parenteral medications.
(b)
If intravenous admixtures are prepared within the Institutional Facility, the
Institutional Pharmacy shall have adequate equipment, personnel, and space for such
preparation. The compounding and labeling of intravenous admixtures, including all
total parenteral nutrition, shall be performed by, or under, the direct supervision of a
pharmacist; however, if twenty-four hour (24-hour) pharmacy service is not provided at
the Institutional Facility, the PIC shall establish written policies and procedures to be
followed in the preparation of intravenous admixtures when the Institutional Pharmacy is
closed or in emergency situations.
(c)
All admixtures shall be labeled with a distinctive supplementary label,
indicating the name and amount of drug added, date and time of addition, expiration date,
and rate of administration, and the name or identification code of the person adding the
drug.
(d)
The PIC shall be responsible for removing concentrated electrolytes
(including, but not limited to, potassium chloride, potassium phosphate, sodium chloride
greater than 0.9%) from patient care areas and limiting their access to pharmacists, if at
all possible. If twenty-four hour (24-hour) on-call status for pharmacists is not available,
the Institutional Facility must utilize the most trained professional available to process
concentrated electrolytes. Training in the safe use of concentrated electrolytes should be
conducted by the Institutional Pharmacy for non-pharmacist staff with access to
concentrated electrolytes. Evidence of training will be documented and retrievable, and
the Institutional Facility will have policies and procedures that detail this process.
Premixed large volume intravenous solutions containing electrolytes and premixed
potassium bolus doses will be used whenever possible.
Section 17.
Practitioner’s Orders.
(a)
All orders for drugs shall be transmitted to the Institutional Pharmacy by
electronic order entry, or by means of an order format that is capable of producing a
direct copy or an electronically reproduced facsimile. A pharmacist shall review the
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practitioner’s order before the initial dose of medication is dispensed provided that, in
emergencies or when pharmacy services are not available, the Medication Order shall be
reviewed by the pharmacist as soon thereafter as possible. Verification of the accuracy of
the medication dispensed and of any transcriptions made of that order shall be
documented by the initials of the pharmacist so certifying.
(b)
Orders for drugs for use by inpatients shall, at a minimum, contain patient
name and location, drug name, strength, directions for use, date, and practitioner’s
signature or signature of practitioner’s agent, either written or electronic signatures.
(c)
Orders for outpatient dispensing shall meet the requirements of Wyoming
Pharmacy Act Rules and Regulations, Chapter 2, Section 19.
Section 18.
Dispensing.
(a)
If unit-dose packaging is used, medication for each patient, when not
supplied by an automated dispensing device, shall be distributed and stored in separate
trays, drawers, compartments, or containers assigned to that patient and bearing the
patient’s name and location.
Section 19.
Investigational Drugs and Protocols.
(a)
All Investigational Drugs shall be stored in the Institutional Pharmacy and
distributed only from the Institutional Pharmacy. Basic information concerning the
dosage form, route of administration, strength, actions, uses, side effects, adverse effects,
interactions, and symptoms of toxicity of such drugs shall be available in the Institutional
Pharmacy. Investigational Drugs shall be properly labeled and shall be administered only
under the personal and direct supervision of the principal physician-investigator or his or
her authorized clinician(s) with prior approval of the appropriate committee(s) of the
Institutional Facility and with verifications that the patient (or his or her legal designee)
has signed the informed consent form.
(b)
A copy of all Investigational Drug protocols shall be on file in the
Institutional Pharmacy.
Section 20.
Inspections.
The Pharmacist-in-Charge or his/her designee shall document on at least a
quarterly basis an inspection of all drug storage areas in the Institutional Facility.
Records of such inspections shall be dated, signed, and maintained so as to be readily
retrievable at the Institutional Pharmacy for at least two (2) years. These inspections
must ascertain that:
(a)
Test reagents, germicides, and disinfectants are stored separately from
medications;
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(b)
External medications are stored separately from internal medications;
(c)
Thermolabile drugs are stored at the proper temperature;
(d)
There are no outdated or deteriorated drugs;
(e)
All drugs are properly labeled;
(f)
Emergency Drug Carts (crash carts) are adequate and in proper supply;
(g)
Medication storage areas are locked when not in use, and only authorized
individuals have access to these areas;
(h)
Distribution and administration of controlled substances are properly and
adequately documented;
(i)
Telephone numbers of the regional poison control center and other
emergency assistance organizations are posted;
(j)
Metric-apothecaries’ weight and measure conversion tables and charts are
available; and
(k)
Adequate pharmaceutical reference texts are at these areas.
Section 21.
Medications brought into the institution by patients.
Whenever patients bring drugs into an Institutional Facility, such drugs shall not
be administered unless they can be precisely identified; administration shall be pursuant
to a practitioner’s order. If such drugs are not to be administered, they shall be delivered
to the Institutional Pharmacy, packaged, sealed, and returned to an adult (18 years or
older) member of the patient’s immediate family (spouse, unless legally separated; adult
child; parent; grandparent; adult brother or sister; adult grandchild), the patient’s legal
guardian or conservator, or the patient’s designated agent, or they shall be stored and
returned to the patient upon discharge, only after advice is provided regarding continuing
the returned medication.
Section 22.
Controlled Drugs.
(a)
All controlled substances issued by the Institutional Pharmacy to any
Institutional Facility department, excluding those controlled substances for which the
dispensing and record-keeping are maintained utilizing an automated drug dispensing
device, shall be labeled and accompanied with control sheets (proof of use forms) that
provide space for recording:
(i)
The drug name, strength, and dosage form;
(ii)
The date and time of administration;
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(iii)
The quantity administered;
(iv)
Name of patient;
(v)
The signature of the nurse who administered the medication, when
issued to nursing units; and
(vi) The signature of the practitioner who administered the medication
and a witness, when issued to surgery.
(b)
Such drugs shall be limited both in kind and quantity commensurate with
the needs of the area to which they are distributed; the Institutional Pharmacy shall
maintain a record of such distribution. The Pharmacist-in-Charge (PIC), in consultation
with the Director of Nursing or other appropriate hospital staff, shall establish written
requirements for the frequency of controlled substance inventories in drug storage areas
outside of the Institutional Pharmacy.
(c)
All control sheets must be returned to the Institutional Pharmacy upon
completion. The pharmacist shall verify the returned sheets for accountability and
control prior to drug reissuance. These control sheets, as well as any records generated,
must be maintained so as to be readily retrievable at the Institutional Pharmacy for two
(2) years. Records of controlled substance, which are dispensed utilizing an automated
drug dispensing device, shall be maintained at the Institutional Pharmacy for two (2)
years.
(d)
All controlled substances that must be wasted shall be destroyed by a
method approved by the PIC. Documentation of all destruction must occur on the control
sheet, in the patient’s medical record, or utilizing the format available with an automated
drug dispensing device, and be signed (written or electronically) by the nurse/physician
destroying and one witness who observed the destruction.
(e)
Transdermal patches containing controlled substances shall be handled in
the following manner:
(i) The PIC, in coordination with the Director of Nursing, will
implement a policy requiring all nursing personnel applying a transdermal patch
containing a controlled substance to write the date on the patch when it is first applied to
a patient.
(ii)
All used transdermal patches containing a controlled substance
shall be destroyed in front of a witness, and documented in a manner similar to Section
22(d). The destruction will be done in a manner that does not subject the health care
worker to exposure to the controlled substance and that makes the patch irretrievable
(e.g., using gloves to cut the patch, placing it in a sharps container, cleaning the scissors
with alcohol, etc.).
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